The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Healthy Dietary Pattern with Cottonseed Oil; Other: Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils; Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil

Detailed Description

This is a 3-period randomized crossover complete feeding study examining if a dietary pattern containing cottonseed oil improves lipids/lipoproteins and other cardiometabolic disease risk factors to a greater extent than a fatty acid matched diet devoid of cottonseed oil and a diet lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA), but with a matched PUFA:SFA ratio

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina Petersen, PhD; Phone Number: 814-865-7206; Email: kup63@psu.edu
• Study Contact Backup: Name: Stacey Meily; Phone Number: 814-863-8622; Email: sas117@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Recruiting
      • The Pennylvania State University
      • Contact: Phone Number: 1-866-778-3438; Email: DCHLab@psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• LDL-C ≥100 mg/dL and ≤190 mg/dL
• BMI of 25-40 kg/m2
• Blood pressure <140/90 mmHg
• Fasting blood glucose <126 mg/dL
• Fasting triglycerides <350 mg/dL
• ≤10% change in body weight for 6 months prior to enrollment

Exclusion Criteria:

• Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
• Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
• Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
• Diagnosed liver, kidney, or autoimmune disease
• Prior cardiovascular event (e.g., stroke, heart attack)
• Current pregnancy or intention of pregnancy within the next 6 months
• Lactation within prior 6 months
• Follows a vegetarian or vegan diet
• Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
• Antibiotic use within the prior 1 month
• Oral steroid use within the prior 1 month
• Use of tobacco or nicotine containing products with in the past 6 months
• Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
• Participation in another clinical trial within 30 days of baseline
• Currently following a restricted or weight loss diet
• Prior bariatric surgery
• Intake of >14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Diet + Cottonseed Oil (CSOD); Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO)	Other: Healthy Dietary Pattern with Cottonseed Oil; Cottonseed Oil
Active Comparator: Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD); Healthy dietary pattern containing 40g/day/2000 kcal of a blend of plant oils comprising a fatty acid profile that matches the CSOD but devoid of CSO	Other: Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils; Plant oil blend fatty acid matched
Active Comparator: Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD); Healthy dietary pattern containing 40g/day/2000 kcal of plant oil that is lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA) than the CSOD, but with a matched PUFA:SFA ratio and devoid of CSO.	Other: Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil; Plant oil with matched PUFA to SFA ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. The mean of the LDL-cholesterol values from day 1 and day 2 testing will be used for analysis.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglycerides concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Total Cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
HDL-cholesterol concentration	Assessed from fasting blood draw expressed in mg/dL	4 weeks
Particle Size and Number of LDL, HDL, VLDL and Chylomicrons	Measured via Nuclear Magnetic Resonance	4 weeks
Central Systolic and Diastolic Blood Pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Brachial Systolic and Diastolic Blood Pressure	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)	4 weeks
Carotid-Femoral Pulse Wave Velocity	A measure of arterial stiffness assessed using a SphymoCor Xcel (Atcor Medical). Expressed in meters/second.	4 weeks
Fasting Serum Insulin concentration	Serum insulin levels assessed in a fasting blood draw and expressed in micro IU/mL	4 weeks
Fasting Plasma Glucose concentration	Glucose assessed in a fasting blood draw and expressed in mg/dL	4 weeks
Fasting Serum Fructosamine concentration	Fructosamine assessed in a fasting blood draw and expressed in micro IU/mL	4 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5	4 weeks
Dihydrosterculic acid	Dihydrosterculic acid assessed from fasting blood draw and measured using Gas-Chromatography-Mass Spectrometry	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of the Gut Microbiota	Abundance measured using 16 s rRNA sequencing	4 weeks
Fatty acids	Fatty acid analysis of red blood cells assessed from fasting blood draw and measured using Gas Chromatography	4 weeks

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Cotton Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Lipids; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Plant Preparations; Biological Products; Complex Mixtures; Plant Oils; Oils; Dietary Fats; Fats; Dietary Fats, Unsaturated; Fats, Unsaturated; Cottonseed Oil
• Other Study ID Numbers: POS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
• IPD Sharing Time Frame: After publication of all pre-specified primary and secondary outcomes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No